STANDARD OPERATING PROCEDURE TONOPORT V

Transcription

1 Page 1 of 24

2 1. Scope This Standard Operating Procedure (SOP) applies to the staff and students using the Tonoport V in the Pharmacy Practice Resource Unit (PPRU) at the Pharmacy Department, University of Malta. 2. Objective To describe the procedure for set-up, configuration, operation, recording and recalling of results, quality control, maintenance and troubleshooting of the Tonoport V. 3. Definitions 3.1. A 100 : Rechargeable batteries have a capacity of 100% (fully charged) b 50 : Alkaline batteries have a capacity of only 50% (half depleted) Button: Displays most recent measurement results or most recent error message, toggles between day and night phase Measurement Protocol: Includes 3 protocols; P1, P2 and P3 Protocol Day Phase (7 a.m. 10 p.m.) Night Phase (10 p.m. 7 a.m.) P1 Every 15 minutes Every 30 minutes P2 Every 20 minutes Every 40 minutes P3 Every 30 minutes Every 60 minutes 3.5. Performance check: Involves running a self-test of the device including all symbols and segments on the LCD. It checks the batteries indicating the remaining capacity. The device will emit an audio signal, if enabled. Upon passing the self-test and completing the battery test, the device will display the time of day, measuring phase (day /night ) and whether data is stored in memory of the device (M) Button: Starts and stops a measurement Tonoport V: A small-size, patient-borne blood pressure (BP) monitor for ambulatory, non-invasive measurement of BP in adults and children for periods of up to 30 hours. BP is measured by the oscillometric method. Page 2 of 24

3 4. Responsibility 4.1. The members of the Department of Pharmacy (staff and students) are responsible for following this SOP The designated Laboratory Officer or Laboratory Assistant is responsible for ensuring that this SOP is followed. 5. Procedure 5.1. Diagram Page 3 of 24

4 5.2. Set-Up Slide the lid of the battery compartment open and pull upwards Place two AA size rechargeable nickel metal hybrid (NiMH) or alkaline batteries in the battery compartment Turn the device On Slide the switch, located inside the battery compartment, to the right, while looking at the display Wait for the time to be displayed six times; display shows H ; display shows AAAA when the device is set up for rechargeable NiMH batteries and bbbb when set up for alkaline batteries to confirm the displayed information or press to change the selection to confirm the new selection; device will briefly display the capacity of the inserted batteries Place the lid on the battery compartment and close Before using the device on a patient: 5.3. Clearing Memory Turn the device On Clear memory (section 5.3) Check date and time and adjust if required (section 5.4) Select pressure unit (section 5.5) Select measurement protocol (section 5.6) Enable/disable audio signal (section 5.7) Switch the device Off and On again Wait for the time to be displayed ; display indicates H ; display indicates LLLL again to delete data; display indicates 0000 followed by the time. Page 4 of 24

5 5.4. Setting Date and Time Switch the device Off and On again Wait for the time to be displayed twice; display indicates H ; display indicates the year Confirm year with if indicated year is correct, or press to correct year followed by to confirm Repeat for month, day, hour and minute Setting ure Unit Switch the device Off and On again Wait for the time to be displayed eight times; display indicates H ; display indicates mmhg or kpa Confirm pressure unit with or select other unit with ; confirm with Selecting Measurement Protocol Switch the device Off and On again Wait for the time to be displayed three times; display indicates H ; display indicates LLLL ; display indicates P1 ; press to select P2 or P to confirm measurement protocol. Page 5 of 24

6 5.7. Enabling/Disabling Audio Signal Switch the device Off and On again Wait for the time to be displayed seven times; display indicates H ; display indicates 0000 when the audio signal is turned off and 1111 when audio signal is turned on to confirm the required setting or press to select the alternate setting and press to confirm Applying the Cuff Select appropriate cuff size Place cuff on the arm of the patient that is used less frequently during normal daily activities; place cuff about 2 fingers breadth above the bend of the elbow in adults and a little close to the bend of the elbow in children Initiating a Trial Measurement Turn device On and place it in the carrying pouch Attach the pouch to the patient using the shoulder strap and belt Guide the pressure tubing around the patient s neck as strain relief and connect it to the BP cuff port on the device Instruct patient to stand or sit, but not to move, during measurement to avoid an erroneous measurement to initiate the first measurement; measured data appears as systolic reading (S), diastolic reading (D) and pulse rate Once successfully completing trial measurement, the device will continue with automatic measurements Data Output Turn device Off Connect device to the PC via cable when using the USB port of the device Turn device On and wait for time to be displayed on device. Page 6 of 24

7 5.11. Software Installation CardioSoft Turn PC and monitor On and exit all programs Insert CardioSoft CD in the CD ROM drive Start setup.exe via Windows Explorer, if CD drive does not automatically start up Follow the displayed prompts Confirm the two proposed directories with Next Enter the serial number from CD-ROM to install CardioSoft Restart Windows USB Driver Turn PC and monitor On and exit all programs Insert the CD with the USB drivers in the CD ROM drive Start setup.exe via Windows Explorer, if CD drive does not automatically start up Follow the displayed prompts select Allow if the system indicates that an unidentified program is being used Click Finish to complete the first part of the USB driver installation procedure Turn device On and connect it to the PC, using the USB connection cable Follow any additional prompts that may be displayed Remove USB driver CD from the CD-ROM drive when Windows indicates that the drivers were successfully installed Turn device On and connect its USB port to the PC to verify USB port. Page 7 of 24

8 5.12. Troubleshooting: Error Codes Page 8 of 24

9 5.13. Cleaning and Disinfection Device Surface Cuffs Turn device Off Wipe the device with a soft, lint-free cloth, using a mild cleaning solution or dishwashing liquid in a low concentration; do not allow liquid to enter the device Use a moist cloth to wipe cuffs which are only slightly soiled Clean cuffs that are heavily contaminated by washing them with soapy water or a suitable cleaning agent that contains a disinfectant; do not machine-wash Ensure that no liquid penetrates into the cuff bladder or the pressure tubing; remove bladder from the cuff before cleaning top avoid this Rinse the cuff thoroughly with water after cleaning and allow it to dry at room temperature for about 15 hours Disinfect the cuffs with 70% isopropyl alcohol or 70% ethanol Rinse cuff thoroughly with tap water and air-dry after disinfection Cables Maintenance Disconnect cables from device before cleaning Use a cloth moistened with soapy water to wipe the cables clean Do not immerse the cables in liquid Check device and cables for signs of mechanical damage before each use Carry out technical safety inspections annually to ensure functional and operational safety The non-invasive pressure measurement system of the device should be inspected every 2 years. Page 9 of 24

10 5.15. Calibration Connect a rubber bulb between pressure tubing and cuff, using a T- adapter Roll up cuff tight Switch device Off and On again after a few seconds Wait for time to be displayed four times; display indicates H ; display indicates an internal value that must be between 25 and Contact service technician if displayed value is outside this range again; display indicates Generate a test pressure of 200mmHg and measure the pressure decrease after waiting at least 30 seconds; pressure decreases between 3 and 5 mmhg are typical; a pressure decrease > 6mmHg indicates a leak Contact service technician if a leak is present to exit the calibration mode. Page 10 of 24

11 5.16. Flowcharts Set-Up Start Slide the lid of the battery compartment open and pull upwards Place 2 AA size (rechargeable nickel metal hybrid (NiMH) or alkaline batteries) in battery compartment Turn device On Slide switch (located inside the battery compartment) to the right Wait for time to be displayed 6 times; display shows H6 ; display shows AAAA when device is set up for rechargeable batteries and bbbb when set up for alkaline batteries to confirm displayed information or press to change selection to confirm new selection; device will briefly display capacity of batteries Place lid on the battery compartment and close End Page 11 of 24

12 Clearing Memory Start Switch the device Off and On again Wait for time to be displayed ; display indicates H1 ; display indicates LLLL again to delete data; display indicates 0000 followed by time End Page 12 of 24

13 Setting Date and Time Start Switch the device Off and On again Wait for time to be displayed twice; display indicates H2 ; display indicates year Confirm year with if indicated year is correct, or press to correct year followed by to confirm Repeat previous step for month, day, hour and minute End Page 13 of 24

14 Setting ure Unit Start Switch the device Off and On again Wait for time to be displayed 8 times; display indicates H8 ; display indicates mmhg or kpa Confirm pressure unit with or select other unit with ; confirm with End Page 14 of 24

15 Selecting Measurement Protocol Start Switch the device Off and On again Wait for time to be displayed 3 times; display indicates H3 ; display indicates LLLL ; display indicates P1 ; press to select P2 or P3 to confirm measurement protocol End Page 15 of 24

16 Enabling/Disabling Audio Signal Start Switch the device Off and On again Wait for time to be displayed 7 times; display indicates H7 ; display indicates 0000 when audio signal is turned Off and 1111 when audio signal is turned On to confirm required setting or press to select alternate setting and press to confirm End Page 16 of 24

17 Applying the Cuff Start Select appropriate cuff size Place cuff on the patient s arm that is used less frequently during normal daily activities; place cuff about 2 fingers breadth above the bend of the elbow in adults and a little close to the bend of the elbow in children End Page 17 of 24

18 Initiating a Trial Measurement Start Turn device On and place it in carrying pouch Attach pouch to the patient using the shoulder strap and belt Guide pressure tubing around patient s neck as strain relief and connect it to BP cuff port on device Instruct patient to stand or sit and not move during measurement to avoid an erroneous measurement to initiate first measurement (measured data appears as systolic reading (S), diastolic reading (D) and pulse rate) Once successfully completing trial measurement, device will continue with automatic measurements End Page 18 of 24

19 Data Output Start Turn device Off Connect device to the PC via cable when using the USB port of the device Turn device On and wait for time to be displayed on device End Page 19 of 24

20 Software Installation Cardiosoft Start Turn PC and monitor On and exit all programs Insert CardioSoft CD in the CD ROM drive Start setup.exe via Windows Explorer, if CD drive does not automatically start up Follow displayed prompts Confirm the two proposed directories with Next Enter the serial number from CD-ROM to install CardioSoft Restart Windows End Page 20 of 24

21 Software Installation - USB Start Turn PC and monitor On and exit all programs Insert the CD with the USB drivers in the CD ROM drive Start setup.exe via Windows Explorer, if CD drive does not automatically start up Follow displayed prompts; select Allow if the system indicates that an unidentified program is being used Click Finish to complete first part of USB driver installation procedure Turn device On and connect it to PC, using the USB connection cable Follow additional prompts that may be displayed Remove USB driver CD from the CD-ROM drive when Windows indicates that the drivers were successfully installed Turn device On and connect its USB port to PC to verify USB port End Page 21 of 24

22 Calibration Start Connect a rubber bulb between pressure tubing and cuff using T-adapter Roll up cuff tight Switch device Off and On again after a few seconds Wait for time to be displayed 4 times; display indicates H4 ; display indicates an internal value that must be between 25 and 100 Contact service technician if displayed value is outside this range again; display indicates 0 Generate test pressure of 200 mmhg and measure pressure decrease after waiting at least 30 seconds (pressure decreases between 3 and 5 mmhg are typical; a pressure decrease > 6mmHg indicates a leak) Contact service technician if a leak is present to exit calibration mode End Page 22 of 24

23 6. Precautions 6.1. Disconnect device from the patient when connecting to PC or other equipment Ensure that liquids do not enter the device; contact service technician before use if liquid has entered the device Disconnect device from other equipment before cleaning Keep device away from magnetic and electrical fields capable of interfering with proper performance of the device leading to incorrect measurements Ensure use of appropriate cuff size; when cuff is too small BP values will be overrated and when cuff is too large BP values will be too low When applying the cuff, bending the arm must not change the cuff level Replace cuff on a regular basis as damaged velcro fasteners may cause incorrect readings Instruct patient to terminate the measurement with, whenever cuff is not deflated within about 2 minutes Instruct patient to remove cuff if it does not deflate after the activation of the button as this could be due to kinked tubing Do not use phenol-based disinfectants or peroxide compounds to disinfect the device. 7. Reference GE Healthcare. Tonoport V Operator s Manual. Berlin, Germany; Page 23 of 24

24 8. Appendices /A1: Function of Button 9. Revision History Version Number Amendments/ Reasons for change 01 Initial Release /A1: Function of Button Page 24 of 24